EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 43 OF 2008
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER SECTION 84AF
Purpose and operation
Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.
Drugs and medicinal preparations to which Part VII applies are declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1). Part VII also applies to certain extemporaneously-prepared medicinal preparations as a result of declarations under paragraph 85(2)(b).
The Minister by legislative instrument can determine the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)); the manner of administration of the form of the listed drug so determined (subsection 85(5)); and a brand of the pharmaceutical item (defined in subsection 84(1)) that has the listed drug in that form with that manner of administration (subsection 85(6)). These determinations govern (except for certain extemporaneously-prepared pharmaceutical benefits) what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act.
Section 84AF empowers the Minister to determine that a person is the responsible person for a brand of a pharmaceutical item. The Minister can do this if the person has notified the Minister that the person is or will be the supplier of the brand of the pharmaceutical item to wholesalers or, if not, to approved pharmacists directly. The brand must be a listed brand (defined in subsection 84(1) as a brand in relation to which a determination under subsection 85(6) is in force), and there can be no determination in force that any other person is the responsible person for the brand of the pharmaceutical item or of any other pharmaceutical item.
A responsible person for a brand of pharmaceutical item has various responsibilities or functions under the Act. These include those in relation to entering into price agreements under section 85AD, compliance with price disclosure requirements under Division 3B, and the requirement to supply certain brands of pharmaceutical item for a specified period under Division 3C.
This instrument determines the responsible persons for the brands of pharmaceutical items set out in Schedule 1 to the instrument. These persons are bodies corporate and are identified in Schedule 1 by their company name and Australian Business Number (ABN). The names of the responsible persons were notified before the commencement of section 84AF as permitted by subsection 84AF(2).
This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends the determination under section 84AF made by legislative instrument number
PB 90 of 2007 which came into effect on 1 December 2007. The amendments are set out in the items of Schedule 1 to the instrument.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 May 2008, was made on 2 April 2008.
Consultations
This instrument affects pharmaceutical companies with medicines listed on the PBS. In relation to the introduction of the responsible person measure, pharmaceutical companies have been consulted during both the policy development and implementation phases. This has occurred through meetings with both peak body organisations and individual companies. Information on this measure has been disseminated through peak industry bodies and during regular meetings with a Stakeholder Reference Group. Particular information on the Responsible Person provisions has been provided by letter to those companies to whom the provisions will apply. Under section 84AF the Minister may only determine a person to be the responsible person for a brand of a pharmaceutical item if the person has notified the Minister that the person is or will be the supplier of the brand of the pharmaceutical item. Each of the persons determined in the instrument to be responsible persons has given the required notification to the Minister.
The PBAC is an independent expert body established by section 100A which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC. When recommending the listing of a medicine on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 May 2008.
Paragraph 2: provides that Schedule 1 amends PB 90 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Additions
Amlodipine Tablet 5 mg (as besylate) (Amlodipine-GA)
Tablet 10 mg (as besylate) (Amlodipine-GA)
Flucloxacillin Powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL (Aspen
Pharmacare Australia Pty Limited)
Powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL (Aspen
Pharmacare Australia Pty Limited)
Gabapentin Tablet 600 mg (Pharmacor Gabapentin 600)
Tablet 800 mg (Pharmacor Gabapentin 800)
Lamotrigine Tablet 25 mg (Lamotrigine generichealth)
Tablet 50 mg (Lamotrigine generichealth)
Tablet 100 mg (Lamotrigine generichealth)
Tablet 200 mg (Lamotrigine generichealth)
Lapatinib Tablet 250 mg (as ditosylate monohydrate) (Tykerb)
Lercanidipine with enalapril Tablet containing lercanidipine hydrochloride 10 mg with enalapril
maleate 10 mg (Zan-Extra 10/10)
Tablet containing lercanidipine hydrochloride 10 mg with enalapril
maleate 20 mg (Zan-Extra 10/20)
Lisinopril Tablet 20 mg (Lisinopril generichealth)
Macrogol 3350 Sachets containing powder for oral solution 6.563 g with electrolytes,
30 (Movicol-Half)
Risedronic acid and calcium Pack containing 4 tablets risedronate sodium 35 mg and 24 sachets
with colecalciferol containing granules of calcium carbonate 2.5 g with colecalciferol
22 micrograms (Actonel Combi D)
Sertraline Tablet 50 mg (as hydrochloride) (Sertra 50)
Tablet 100 mg (as hydrochloride) (Sertra 100)
Tramadol Tablet containing tramadol hydrochloride 100 mg (sustained release)
(Tramedo SR 100)
Tablet containing tramadol hydrochloride 150 mg (sustained release)
(Tramedo SR 150)
Tablet containing tramadol hydrochloride 200 mg (sustained release)
(Tramedo SR 200)
Deletions
Amoxycillin Tablet 1g (as trihydrate) (Amoxil Duo)
Flucloxacillin Capsule 250 mg (as sodium) (Floxapen)
Capsule 500 mg (as sodium) (Floxapen)
Isosorbide Dinitrate Tablet 10 mg (Isordil)
Salmeterol Pressurised inhalation 25 micrograms (as xinafoate) per dose, 120 doses
(Serevent)
Alteration of Responsible Person
“Sandoz Pty Ltd” has been omitted and substituted with “sanofi-aventis Australia Pty Ltd” for the following items:
Fluconazole Capsule 100 mg (Fluconazole Winthrop)
Capsule 200 mg (Fluconazole Winthrop)
Fosinopril Tablet containing fosinopril sodium 10 mg (Fosinopril Winthrop)
Tablet containing fosinopril sodium 20 mg (Fosinopril Winthrop)
Fosinopril with Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide
Hydrochlorothiazide 12.5 mg (Fosinopril/HCT Winthrop 10mg/12.5mg)
Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide
12.5 mg (Fosinopril/HCT Winthrop 20mg/12.5mg)
Lisinopril Tablet 5 mg (Lisinopril Winthrop)
Tablet 10 mg (Lisinopril Winthrop)
Tablet 20 mg (Lisinopril Winthrop)
Paroxetine Tablet 20 mg (as hydrochloride) (Paroxetine Winthrop)
“Hospira Australia Pty Ltd” has been omitted and substituted with “Orphan Australia Pty Ltd” for the following items:
Tiagabine Tablet 5 mg (as hydrochloride) (Gabitril)
Tablet 10 mg (as hydrochloride) (Gabitril)
Tablet 15 mg (as hydrochloride) (Gabitril)
“Merck Sharp & Dohme (Australia) Pty Ltd” has been omitted and substituted with “PharmaLink Pty Ltd” for the following item:
Ethacrynic Acid Tablet 25 mg (Edecrin)